Exact FDA event identifier

Event 81383

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

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Event summary

Timeline bucket: October 14, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Helena Laboratories, 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

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Z-2434-2019

Recall number: Z-2434-2019
Initiated: October 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Helena Laboratories, Inc.
Quantity: 65 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

Code information

Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360

Distribution pattern

Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea