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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65874

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Celera Corporation

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

OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.

Z-2096-2013
Recall number
Z-2096-2013
Initiated
July 12, 2013
Classification
Class III
Status
Terminated
Recalling firm
Celera Corporation
Quantity
43 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.

Code information

Lot numbers: 10016853, 10017390, 10020343, 10021820 and 10022594. Expiry dates 12/5/2010, 06/15/2012, 09/08,2012, 08/13/2013 and 02/21/2014.

Distribution pattern

USA Nationwide in the state of CA