CLASS II ONGOING Device recall · Reported 31 May 2023 · FDA Enforcement Report

Atellica CH Toxicology Calibrator recalled

Siemens Healthcare Diagnostics is recalling Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX, distributed nationwide in the US. The recall was initiated on 5 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDi-DI: 00630414597614 Lot Numbers: 74285306 Exp. Date: 2023-05-31; 74536672 Exp Date: 2024-03-31; 74732386 Exp. Date: 2024-11-30

Quantity recalled6546 units US; 3681 units 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-1632-2023
FDA event ID: 92179
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Ongoing
Recall initiated: 5 Apr 2023
FDA classified: 25 May 2023
Reported: 31 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

5 Apr 2023	Recall initiated by company
25 May 2023	Classified by FDA	+50 days
31 May 2023	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

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

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

Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440

Where it was distributed

US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Canada Chile China Colombia Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hong Kong Hungary¿¿¿¿¿¿¿¿ India Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Malaysia Mexico Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Republic of Korea Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Taiwan Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay Vietnam

Nationwide Georgia

Questions about this recall

Why was it recalled?

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

Which lots are affected?

UDi-DI: 00630414597614 Lot Numbers: 74285306 Exp. Date: 2023-05-31; 74536672 Exp Date: 2024-03-31; 74732386 Exp. Date: 2024-11-30

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 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.

Other products in this recall event

1 other product · FDA event 92179

Reported	Class	Recall	Company	Reason	Where
31 May 2023	CLASS II	Advia Chemistry ToxAmmonia Calibrator- In vitro diagnostic recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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