CLASS III Device recall · Reported 1 May 2013 · FDA Enforcement Report
Vitros¿ Immunodiagnostic Products Anti-HBs recalled
Ortho-Clinical Diagnostics is recalling Vitros¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface. The recall was initiated on 1 Nov 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1161-2013
- FDA event ID
- 64739
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Nov 2012
- FDA classified
- 23 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Nov 2012 | Recall initiated by company | |
| 23 Apr 2013 | Classified by FDA | +173 days |
| 1 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Product as listed by the FDA
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Where it was distributed
Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Questions about this recall
Why was it recalled?
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Which lots are affected?
Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
Where was it sold?
Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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