Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40… recallZ-0468-2016 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 19, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.
FDA root cause category: Employee error
What the company is doing
Siemens sent an Urgent Medical Device Correction Letter dated November 19, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by Customers: If you are using the affected lot of Factor VIII Chromogenic Assay on a Sysmex CA-1500 or CA-7000 System, please discontinue use. - Due to a different detection principle, the use on BCS and BCS XP is not affected and you can continue using the product on BCS / BCS XP. - Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. - Review your inventory of this product to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Corrective Action: The Factor VIII Chromogenic Assay Lot Number 44637 kits were placed on product hold on August 19, 2015, at the Siemens Distribution Centers. For further questions, please call ( 914) 524 - 2495.
Recall details
- Recall number
- Z-0468-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 19, 2015
- Posted by the FDA
- Dec 22, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- Domestic: 52 kits, Foreign: 623 kits
- Product code
- GGP
- FDA submissions
- K884544
- Distribution
- Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.
Product description
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Code information (models, lots, serial numbers)
Lot Number 44637, exp. 2016-11-30
Other devices under the same FDA submission
1 device cleared under K884544 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Factor VIII Chromogenic Assay 10445729Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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