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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93300

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

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Event summary

Timeline bucket
October 02, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stanbio Laboratory, LP

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

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

Z-0490-2024
Recall number
Z-0490-2024
Initiated
October 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Stanbio Laboratory, LP
Quantity
2,351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

Code information

UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.