Exact FDA event identifier

Event 77445

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 19, 2011
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Medtest Holdings, Inc.

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

1 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 1

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

Z-2650-2017

Recall number: Z-2650-2017
Initiated: October 19, 2011
Classification: Class III
Status: Terminated
Recalling firm: Medtest Holdings, Inc.
Quantity: 319.922 L

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Linear performance information in product insert does not match that listed in the approved premarket notification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Linear performance information in product insert does not match that listed in the approved premarket notification

Code information

Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.

Distribution pattern

Nationwide Distribution