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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88323

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 12, 2021
Product types
Device
Classifications
Class III
Statuses
Terminated
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

5 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 5

Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

Z-2199-2021
Recall number
Z-2199-2021
Initiated
July 12, 2021
Classification
Class III
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
7,108 products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information

Catalog Number/Product Description: 2440-058/¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000519 Lot Numbers: 164312; 161081; 161039; 161031; 158972;

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

device · product 2 of 5

Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

Z-2200-2021
Recall number
Z-2200-2021
Initiated
July 12, 2021
Classification
Class III
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information

Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

device · product 3 of 5

Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Z-2201-2021
Recall number
Z-2201-2021
Initiated
July 12, 2021
Classification
Class III
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information

Catalog Number/Product Description: B2440-180/Synchron CX/DX/LX ¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000526 Lot Numbers: 161020;

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

device · product 4 of 5

Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Z-2202-2021
Recall number
Z-2202-2021
Initiated
July 12, 2021
Classification
Class III
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
3,940 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information

Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

device · product 5 of 5

Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

Z-2203-2021
Recall number
Z-2203-2021
Initiated
July 12, 2021
Classification
Class III
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
93 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information

Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.