AMS Diagnostics, LLC: Medical Device Recall in 2014 - (Recall #: Z-1269-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 11, 2014

Date Posted: April 2, 2014

Recall Number: Z-1269-2014

Event ID: 67599

Reason for Recall:

Marketing the devices outside 510(k) requirements

Status: Terminated

Product Quantity: 116 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated