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Recall Observatory FDA recall evidence

Device product

VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

Z-0557-2014

October 25, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 66900
Status
Terminated
Classification
Class II
Quantity
1,920 kits
Official record key
device-enforcement:Z-0557-2014

Official wording

Reason: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.

Code information: Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013

Distribution pattern: Nationwide distribution - all states.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.