CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Vitros Chemistry Products GLU Slides-Product recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products GLU Slides, distributed nationwide in the US. The recall was initiated on 17 Jun 2019 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-2202-2019
- FDA event ID
- 83228
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2019
- FDA classified
- 6 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 17 Jun 2019 | Recall initiated by company | |
| 6 Aug 2019 | Classified by FDA | +50 days |
| 14 Aug 2019 | 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
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Product as listed by the FDA
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Where it was distributed
US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutFloridaKansasKentuckyMassachusettsMinnesotaTennessee
Questions about this recall
Why was it recalled?
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Which lots are affected?
Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572
Where was it sold?
US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
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.
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |