LABCON, NORTH AMERICA
14 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (14)
Devices registered here (1)
- Tube, Tissue CultureProduct code KJG (opens in a new tab) · Class I · Pathology · 21 CFR 864.3010
Recalls & enforcement
20231 record
- Class IIOngoing2023-05-02Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
20221 record
- Class IIOngoing2022-04-06Due to microbial growth causing interference with interpretation.
20211 record
- Class IITerminated2021-01-05Intermittent potential for shorter than expected clot times.
20201 record
- Class IIOngoing2020-11-09Due to complaints received associated with cracked/split test tube caps.
20183 records
- Class IIOngoing2018-08-08The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
- Class IIIOngoing2018-05-23Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
- Class IIIOngoing2018-02-27Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
20174 records
- Class IITerminated2017-12-07Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
- Class IITerminated2017-07-21The plates do not have wells punched for the controls in the patient 1 area.
- Class IITerminated2017-04-04Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
- Class IITerminated2017-02-24Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
20163 records
- Class IIITerminated2016-11-07Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
- Class IITerminated2016-10-14Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
- Class IITerminated2016-04-20Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Related
- All facilities operated by HELENA LABORATORIES, CORP.
- HELENA LABORATORIES, CORP. (TX)
- HELENA LABORATORIES, CORP. (TX)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “LABCON, NORTH AMERICA (FEI 2916657) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2916657-labcon-north-america/
Alerts for LABCON, NORTH AMERICA
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.