Exact FDA event identifier

Event 67599

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 11, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AMS Diagnostics, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

Z-1267-2014

Recall number: Z-1267-2014
Initiated: February 11, 2014
Classification: Class II
Status: Terminated
Recalling firm: AMS Diagnostics, LLC
Quantity: 167 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketing the devices outside 510(k) requirements

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Marketing the devices outside 510(k) requirements

Code information

Model Numbers: 40072, 40146, 81046. 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.

device · product 2 of 3

AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

Z-1268-2014

Recall number: Z-1268-2014
Initiated: February 11, 2014
Classification: Class II
Status: Terminated
Recalling firm: AMS Diagnostics, LLC
Quantity: 13 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketing the devices outside 510(k) requirements

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Marketing the devices outside 510(k) requirements

Code information

Model Numbers: 40147, 80147. Lot codes: 131253, 131254, 131255.

Distribution pattern

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

device · product 3 of 3

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

Z-1269-2014

Recall number: Z-1269-2014
Initiated: February 11, 2014
Classification: Class II
Status: Terminated
Recalling firm: AMS Diagnostics, LLC
Quantity: 116 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketing the devices outside 510(k) requirements

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Marketing the devices outside 510(k) requirements

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.