Z-0490-2024Class II

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

Name: Z-0490-2024 STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone...
Creator: Stanbio Laboratory, LP
Published: 2023-10-02
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2023-10-02 / Open, Classified

FDA source

Stanbio Laboratory, LP began a recall of STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values on 2023-10-02. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0490-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-02
Posted: 2023-12-06
Recalling firm: Stanbio Laboratory
Product: STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Product code: JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Reason for recall: 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: 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 [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).
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0490-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0490-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06

Product code JIN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)