ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A. · Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Open FDA's page for this record- Cfres ID
- 212252
- Product res number
- Z-1248-2025
- Event date initiated
- 2025-01-15
- Event date posted
- 2025-02-27
- Recall status
- Open, Classified
- Res event number
- 96176
- Product code
- FRC
- Product description
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Firm FEI number
- 3013145340
- Recalling firm
- TERRAGENE S.A.
- Address 1
- Ruta Nacional N 9, Km 280, Cp 2130 9 parque industrial micropi km 280
- Address 2
- Cp 2130
- City
- Alvear
- Country
- Argentina
- Additional info contact
- Maximiliano Catalano 341 -837-7243
- Reason for recall
- Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
- Root cause description
- Labeling False and Misleading
- Product quantity
- 914 devices in the U.S.
- Distribution pattern
- US Nationwide distribution in the states of CA and KY.
- Code info
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
- Action
The recalling firm issued an email on 1/15/2025 to the main office of the distributor with an attached Distributor Customer Communication letter dated 1/15/2025, an Acknowledgement and Receipt Form, an updated IFU (Rev.B R01), and a User Letter for the distributor to issue to their customers. The letter to the distributor explains that all product is affected that contains version Rev.A R0 of the IFU because a discrepancy was identified in that version. The Distributor is to review their inventory records for the affected product, identify customers that received or may have received the devices and report it to the recalling firm through the provided Acknowledgement and Receipt Form via email. The Distributor is informed the product can be used according to the enclosed updated IFU (Rev.B R01). The Distributor was requested to notify their customer by using the enclosed User Letter and include the updated IFU with the User Letter. The Distributor is also informed they can continue distribution of their inventory by sending the digital user letter and the updated digital IFU with each delivery. An updated printed IFU will also be made available to users upon request. The User Letter was similar to the Distributor letter except that it instructs the user to discard older version of the IFU (Rev.A R0 and use the product according to the IFU attached to the letter and available on the firm's website. an Acknowledgement and Receipt Form was also enclosed for completion and return.
- K numbers
- K163646
- Harmonized identifiers (openFDA)
- Device name
- Indicator, Biological Sterilization Process
- Medical specialty description
- General Hospital
- Regulation number
- 880.2800
- Device class
- 2
- K number
- K770953, K872867, K112018, K172432, K251122, K855120, K233681, K190297, K930682, K200970, K822024, K910417, K103277, K993775, K163144, K802228, K213881, K852192, K211705, K073244, K004009, K191021, K160546, K092755, K140708, K925745, K894399, K192980, K962441, K863122, K122044, K981497, K071014, K121484, K032914, K020026, K140499, K884767, K183294, K141244 +166 more
- Registration number
- 1720309, 3016678045, 3013145340, 3013298431, 3014579161, 3012421607, 3015392401, 3030733800, 3007412809, 1319130, 3014421917, 2133641, 3030626857, 2432141, 2084725, 3000251274, 3042272797, 3008925937, 2029076, 3017524825, 3011061109, 3004080920, 3031757047, 3012723641, 2410251, 8030087, 3043226252, 9611959, 3012494290, 3013557562, 3004634710, 2183301, 3036504234, 2028456, 3038718579, 3016075971, 3003476474, 3031841433, 2434982, 3009609218 +2 more
- FEI number
- 1720309, 3000203466, 3016678045, 3013145340, 3002677549, 3013298431, 3014579161, 3012421607, 3015392401, 3030733800, 3007412809, 1319130, 3014421917, 3003662624, 3030626857, 2432141, 3000251274, 3042272797, 3005343391, 3008925937, 3017524825, 3011061109, 3004080920, 3031757047, 2410251, 1000160630, 3043226252, 1000125215, 3014534, 3012494290, 3013557562, 3004634710, 2183301, 3036504234, 3038718579, 3016075971, 3003476474, 3031841433, 2434982, 3009609218 +2 more