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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86586

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Hardy Diagnostics

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

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Z-0441-2021
Recall number
Z-0441-2021
Initiated
October 06, 2020
Classification
Class III
Status
Terminated
Recalling firm
Hardy Diagnostics
Quantity
8,620 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

Code information

Lot # 465086

Distribution pattern

US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam