FDAClass IIJanuary 1, 2014

VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent recall

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

Why was VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Recalling firm
Ortho-Clinical Diagnostics
Quantity
1,920 kits
Distribution
Nationwide distribution - all states.
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls