VITROS Immunodiagnostic Products Troponin I ES Calibrators
FDA device recall Z-2358-2023 · posted 2023-08-08 · Open, Classified
Recall details
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Reason for recall
- Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- Action taken
- Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MMI
- Quantity affected
- 4,013 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2023-06-05
- Date posted
- 2023-08-08
- Location
- Bridgend, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838) | Ortho-Clinical Diagnostics | 2006-12-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK (K992366) | Ortho-Clinical Diagnostics, Inc. | 1999-10-08 |