Alere San Diego: Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device, 25T, StanBio (6100-025L), E-Z Well Strep A Test Device, 5T, StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette, McKesson (32-502); Poly stat Strep A Cassette Test, Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test, Cardinal Health (B1077-26). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

Recall number

Z-1074-2012

Recalling firm

Alere San Diego

Product

Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device, 25T, StanBio (6100-025L), E-Z Well Strep A Test Device, 5T, StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette, McKesson (32-502); Poly stat Strep A Cassette Test, Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test, Cardinal Health (B1077-26). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

Status

Terminated

Initiated

2011-09-01

Posted

2012-02-22

Terminated

2012-06-28

Reason

Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.

Root cause

Process change control

Action

The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form. Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.

Quantity

1,859,430 devices (228 lots)

Distribution

Worldwide distribution: USA (nationwide) and countries of : Austria, Canada, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, and United Kingdom.

Lot, serial or model codes

All lots of Cassette product manufactured since August 2009.

510(k) numbers

["K031784"]

PMA numbers

not on file

Product code

GTY

Firm FEI

1000125596

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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