Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label:
FDA device recall Z-0299-04 · 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
- U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHX
- Quantity affected
- 524 reagent packs
- Distribution
- 154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argenti
- Date initiated
- 2003-12-03
- Date posted
- 2004-01-06
- Date terminated
- 2004-02-20
- Location
- Rochester, NY
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