CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report

AMS AST For the In vitro quantitative determination of AST recalled

AMS Diagnostics is recalling AMS AST For the In vitro quantitative determination of AST in serum Quantitative, distributed nationwide in the US. The recall was initiated on 11 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.

Quantity recalled116 kits

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-1269-2014
FDA event ID: 67599
Recalling firm: AMS Diagnostics, Weston, FL
Classification: Class II
Status: Terminated
Recall initiated: 11 Feb 2014
FDA classified: 21 Mar 2014
Reported: 2 Apr 2014
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: Test Kits & Diagnostics

Timeline

11 Feb 2014	Recall initiated by company
21 Mar 2014	Classified by FDA	+38 days
2 Apr 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Marketing the devices outside 510(k) requirements

Product as listed by the FDA

AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.

Where it was distributed

Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

Nationwide California Florida Georgia Massachusetts Maryland North Carolina South Carolina Texas Wyoming

Questions about this recall

Is AMS AST For the In vitro quantitative determination of AST in serum Quantitative recalled?

Yes. AMS Diagnostics recalled AMS AST For the In vitro quantitative determination of AST in serum Quantitative on 11 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1269-2014.

Why was it recalled?

Marketing the devices outside 510(k) requirements

Which lots are affected?

Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.

Where was it sold?

Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

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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