Greer Laboratories, Inc. Recall 91078
Description: GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Greer Laboratories, Inc. Recall 91078 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0347-2023 |
| Event ID | 91078 |
| Event Description | GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies. |
| Product Type | Devices |
| Distribution | US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark |
| Quantity | 218 units |
| Recall Reason | The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted. |
| Device Classification | 20221207 |
| Device Code Info | Lot Number 389591, exp 6/12/2023 |
| Center Classification Date | 20221130 |
| Recall Initiation Date | 20221025 |
| Recalling Firm | Greer Laboratories, Inc. |
| Initial Notification | Telephone |
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