ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-12
FDA device recall Z-0927-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Innominata Dba Genbio
- Reason for recall
- Multiple incidents of low-reacting assay plates.
- Action taken
- The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LSR
- Quantity affected
- 195
- Distribution
- Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
- Date initiated
- 2013-02-11
- Date posted
- 2013-03-08
- Date terminated
- 2013-08-27
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMUNOWELL BORRELIA (LYME)TEST (K911590) | General Biometrics, Inc. | 1991-12-20 |