Biosite Inc Dba Innovacon Inc.: SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay 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-1395-2011

Recalling firm

Biosite Inc Dba Innovacon Inc.

Product

SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay 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

2011-01-12

Posted

2011-02-22

Terminated

2012-06-26

Reason

The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product has demonstrated an elevated Incidence of non-specific binding, potentially causing false positive results. A false positive test result could lead to the administration of antibiotics that are unnecessary. This exposes the

Root cause

Pending

Action

The firm, Alere San Diego, sent a "URGENT MEDICAL DEVICE RECALL" letter dated January 17, 2011. The letter described the product, problem and action to be taken by customers. The customers were instructed to: (1) Immediately discontinue use of the affected lot (if applicable) and inventory remaining full or partial kits at their site (if applicable); (2) Destroy any remaining inventory of this lot and document destruction per their site requirements (if applicable); (3) Complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of this notice and to receive replacement of their remaining inventory of this lot (if applicable). The customers were ask to please return the form even if they have no remaining inventory or do not have any involved product in order to confirm receipt of this notification; and (4) to please ensure that all users of the device have received a copy of this Urgent Medical Device Recall. Customers with questions about the information contained in the notice were instructed to contact Technical Services at 888-246.7483, option 2 or by e-mail attechservices@alere.com.

Quantity

814 kits/24,420 devices

Distribution

Nationwide distribution

Lot, serial or model codes

Lot #: STA0010037

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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