Stanbio Laboratory, LP: STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

Recall number

Z-0490-2024

Recalling firm

Stanbio Laboratory, LP

Product

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

Status

Open, Classified

Initiated

2023-10-02

Posted

2023-12-06

Terminated

not on file

Reason

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

Root cause

Component change control

Action

On 10/2/23, recall notices were sent to customers who were asked to do the following: 1) Discontinue use, quarantine and dispose of any remaining inventory of the identified affected product/lot(s). 2) Ensure this information is shared with your laboratory staff and other pertinent personnel. 3) If you are a distributor, complete and return the Customer Response Form and forward the recall notification to your customers/end-users without delay for completion and return. 4) If you are the end user in receipt of the recall notification from the distributor, please complete the Customer Response Form and return it to the distributor. 5) If you are an end user in receipt of the recall notification directly from the recalling firm, complete and return the Customer Response Form. 6) If you have supplied the product to another laboratory, provide them a copy of this voluntary recall notification for completion and return notification for the same action. 7) Ensure a copy of this notification is retained as part of your laboratory Quality System records. 8) Complete and return the response form to productsafety@ekfdiagnostics.com Until the investigation is finalized, if you have further questions and/or would like to discuss possible alternative products, please contact Technical Support at; 1-800-531-5535 ext. 128. Monday through Friday, 08:00 to 17:00 (CST).

Quantity

2,351

Distribution

Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.

Lot, serial or model codes

UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30

510(k) numbers

not on file

PMA numbers

not on file

Product code

JIN

Firm FEI

1616487

Firm city

Boerne

Firm state

TX

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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