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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70352

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

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Event summary

Timeline bucket
January 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Haemonetics 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

Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

Z-1130-2015
Recall number
Z-1130-2015
Initiated
January 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
4,143 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

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

Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

Code information

Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017

Distribution pattern

Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.