Recall Z-0490-2024 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
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.
| Date | Dec 6, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.