Home / Recalls / AMS Diagnostics, LLC / Z-1269-2014

Z-1269-2014 Class II Terminated

Recalled by AMS Diagnostics, LLC — Weston, FL

FDA device recall Z-1269-2014 was initiated by AMS Diagnostics, LLC on February 11, 2014 and is designated Class II. Reason for recall: Marketing the devices outside 510(k) requirements The recall status is terminated (terminated September 29, 2016). Affected quantity: 116 kits.

Recall Details

Product Type
Devices
Report Date
April 2, 2014
Initiation Date
February 11, 2014
Termination Date
September 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
116 kits

Product Description

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

Reason for Recall

Marketing the devices outside 510(k) requirements

Distribution Pattern

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

Code Information

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

Other recalls by AMS Diagnostics, LLC

  • Z-2725-2017 Class III — Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers (February 29, 2016)
  • Z-1267-2014 Class II — AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrog (February 11, 2014)
  • Z-1268-2014 Class II — AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum (February 11, 2014)

FDA data resources