CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Vitros Chemistry Products Calibrator Kit 2- Ivd calibrator recalled

Ortho Clinical Diagnostics is recalling Vitros Chemistry Products Calibrator Kit 2- Ivd calibrator for Vitros 250/350/5,1, distributed nationwide in the US. The recall was initiated on 16 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021. UDI: 10758750009503

Quantity recalled39709 units (12734 US and 26975 OUS)

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-1226-2020
FDA event ID: 84654
Recalling firm: Ortho Clinical Diagnostics, Raritan, NJ
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2019
FDA classified: 13 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Dec 2019	Recall initiated by company
13 Feb 2020	Classified by FDA	+59 days
19 Feb 2020	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 Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

Product as listed by the FDA

VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659

Where it was distributed

Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands

Nationwide

Questions about this recall

Is Vitros Chemistry Products Calibrator Kit 2- Ivd calibrator for Vitros 250/350/5,1 recalled?

Yes. Ortho Clinical Diagnostics recalled Vitros Chemistry Products Calibrator Kit 2- Ivd calibrator for Vitros 250/350/5,1 on 16 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1226-2020.

Why was it recalled?

Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

Which lots are affected?

Lot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021. UDI: 10758750009503

Where was it sold?

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 21 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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