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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83155

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

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Event summary

Timeline bucket
June 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Randox Laboratories, Limited

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

Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

Z-2150-2019
Recall number
Z-2150-2019
Initiated
June 11, 2019
Classification
Class II
Status
Terminated
Quantity
149 (US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

Code information

1306UN, 1308UN, 1309UN

Distribution pattern

US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.