Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-C
FDA device recall Z-0298-04 · posted 2004-01-06 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
- Action taken
- Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHX
- Quantity affected
- 774 reagent packs
- Distribution
- 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
- Date initiated
- 2003-11-26
- Date posted
- 2004-01-06
- Date terminated
- 2004-02-20
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068) | Ortho-Clinical Diagnostics | 1999-10-04 |