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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84514

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

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Event summary

Timeline bucket
March 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Response Biomedical Corp.

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

Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.

Z-1461-2020
Recall number
Z-1461-2020
Initiated
March 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Response Biomedical Corp.
Quantity
543 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.

Code information

Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318). UDI Code: (01) 1 0627966 00508 4 (10) 070318 (17)300919

Distribution pattern

Worldwide distribution: US Nationwide distributions in the states of IN, GA, OK, KS, AZ, SC, NE, NC, MI, FL, CA, MN, and AR. Countries of Canada, Italy, Malaysia, Kuwait, Saudi Arabia, UAE, Ukraine, Russia, Dominican Republic, France, Mexico, Colombia, Singapore, China, Serbia, Romania, and Philippine.