CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Vitros Immunodiagnostic Products Anti HBs Calibrators recalled
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products Anti HBs Calibrators, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.
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-2142-2024
- FDA event ID
- 94679
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 13 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 13 Jun 2024 | Classified by FDA | +104 days |
| 19 Jun 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for positively biased results due to signal reduction over shelf life.
Product as listed by the FDA
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMontanaNorth CarolinaNew JerseyNew YorkOhio
Questions about this recall
Why was it recalled?
Potential for positively biased results due to signal reduction over shelf life.
Which lots are affected?
Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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