Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #6
FDA device recall Z-1053-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Random occurrence of false positive test results.
- Action taken
- Domestic: Phone calls on 6/7-8/2004. Recall letters sent Federal Express on 6/7/2004. Foreign affiliates notified via e-mail on 6/7/2004. Customers instructed to discard inventory and notify health care providers. EXPANDED: Domestic: 7/1/2004 phone calls and faxes to consignees. FED EX letters mailed on 7/2/2004. Foreign affiliates notified via email on 6/30/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04)
- Distribution
- 4,665 reagent packs shipped to domestic customers nationwide, including 8 federal government accounts (contract #V797P-6565A). 520 reagent packs shipped to 22 foreign affiliates who further distribute
- Date initiated
- 2004-06-07
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-18
- 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 TROPONIN I REAGENT PACK AND CALIBRATORS (K031031) | Ortho-Clinical Diagnostics, Inc. | 2003-09-29 |