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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64469

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

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Event summary

Timeline bucket
February 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microbiologics 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

Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.

Z-1021-2013
Recall number
Z-1021-2013
Initiated
February 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Microbiologics Inc
Quantity
396 boxes of 10 slides each.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote

Code information

SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337

Distribution pattern

Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.