No image published for this recall

No image published for this recall

Ortho-clinical Diagnostics VITROS Immunodiagnostic Products Troponin I ES Calibrators - safety alert

Official notice

16 Aug 2023

Last checked

16 Aug 2023

Medium riskFDA

An official FDA notice concerns Ortho-clinical Diagnostics VITROS Immunodiagnostic Products Troponin I ES Calibrators - safety alert. An official FDA notice concerns VITROS Immunodiagnostic Products Troponin I ES Calibrators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-08-16. Recall numbers: Z-2358-2023. Check the official notice for the complete list. Published 2023-08-16.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

4,013

Recall number

Z-2358-2023

Official notice

2023-08-16

The hazard

An official FDA notice concerns VITROS Immunodiagnostic Products Troponin I ES Calibrators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-08-16. Recall numbers: Z-2358-2023. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 10758750002511

Event Ids

92662

Recall Numbers

Z-2358-2023

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Affected products

Product 1

VITROS Immunodiagnostic Products Troponin I ES Calibrators

Units affected

4,013

Risk / hazard

An official FDA notice concerns VITROS Immunodiagnostic Products Troponin I ES Calibrators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-08-16. Recall numbers: Z-2358-2023. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

GB · United Kingdom · N/A · Bridgend

Affected area 1

GB · United Kingdom · N/A · Bridgend

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Ortho-clinical Diagnostics. Contact: ORTHO-CLINICAL DIAGNOSTICS.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2358-2023

Event id

92662

Units affected

4,013

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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