CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report
Vitros Chemistry Products Calibrator Kit 11 Vanc Reagent recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Calibrator Kit 11 Vanc Reagent Generation (Gen) 50 with Assay, distributed nationwide in the US. The recall was initiated on 14 Apr 2023 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-1664-2023
- FDA event ID
- 92245
- Recalling firm
- Ortho-Clinical Diagnostics, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Apr 2023
- FDA classified
- 30 May 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Apr 2023 | Recall initiated by company | |
| 30 May 2023 | Classified by FDA | +46 days |
| 7 Jun 2023 | 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
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Where it was distributed
Nationwide Foreign: Brazil, Chile, Colombia
Questions about this recall
Why was it recalled?
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Which lots are affected?
UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Where was it sold?
Nationwide Foreign: Brazil, Chile, Colombia
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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