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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71953

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

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Event summary

Timeline bucket
March 13, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pointe Scientific, 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

Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

Z-2764-2015
Recall number
Z-2764-2015
Initiated
March 13, 2015
Classification
Class III
Status
Terminated
Recalling firm
Pointe Scientific, Inc.
Quantity
H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.

Code information

Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402

Distribution pattern

Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.