IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling
Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding regulatory status (IVD vs. Research Use Only) rather than a direct physical or chemical hazard causing injury.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. The affected product is packaged in a cardboard box containing plastic bottles and is used for quality control of the IDS-iSYS Ostase BAP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated because staff at IDS Inc. noted that the stock is labeled with IVD (In Vitro Diagnostic) labels, although the products are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only, depending on their usage.
The recall involves Lot 1177 with an expiration date of August 2012. The products were distributed nationwide, including in New York, California, Maine, and Connecticut. Users should stop using the affected control sets and contact the manufacturer for further instructions.
The recalled product
- Product
- IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase)…
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1177
- EXP Aug 2012
Distribution
Part of a larger recall action
This product is one of 7 recalled by Immunodiagnostics Systems Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Immunodiagnostics Systems Ltd
See all →- ModerateIDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling
FDA (Devices) · 2012-10-17
- ModerateIDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling
FDA (Devices) · 2012-10-17
- ModerateIDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling
FDA (Devices) · 2012-10-17
- ModerateIDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors
FDA (Devices) · 2012-10-17
- ModerateImmunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error
FDA (Devices) · 2012-10-17
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowHelena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits
FDA (Devices) · 2018-12-12
- LowTosoh AIA-PACK TPOAb Control Set Recalled for Labeling Errors
FDA (Devices) · 2017-06-07
- LowTosoh Bioscience Recalls AIA-PACK TgAb Control Set Due to Labeling Error
FDA (Devices) · 2017-06-07
- LowBiochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies
FDA (Devices) · 2015-12-02
- LowRandox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values
FDA (Devices) · 2019-04-17
- LowMedtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
FDA (Devices) · 2017-07-05