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STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB… recallZ-0490-2024 · Stanbio Laboratory, LP · initiated Oct 2, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stanbio Laboratory, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component change control

What the company is doing

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 [email protected] 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).

Recall details

Recall number
Z-0490-2024
Status
Open, Classified
Initiated by the company
Oct 2, 2023
Posted by the FDA
Dec 6, 2023
Recalling firm
Stanbio Laboratory, LP
Quantity
2,351
Product code
JIN
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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